Prediction of Major Bleeding in ELBW-infants (<1000g) by Sequential Coagulation Monitoring

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Nadja Haiden,MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01976013
First received: October 29, 2013
Last updated: December 21, 2014
Last verified: December 2014
  Purpose

Up to now, only data about early and single coagulation screening exist in extreme low birth weight infants (ELBW) infants. In neonatal practice, coagulation abnormality in preterm babies is primarily investigated by measuring prothrombin time (PT). In fact, FVII activity, which is an important determinant of PT, is strongly associated with bleeding risk. Thus, a method to measure PT with small volume samples (10μL) provides the possibility for serial monitoring even in ELBW infants (CoaguChek®XS, Roche Diagnostics, Vienna, Austria)). Substitution of fesh frozen plasma seemed beneficial in ELBW infants and first trials with rFVII revealed promising results in this patient population. Thus, coagulation monitoring might lead to early and adequate therapy and therefore to a better outcome. The investigators hypothesize that ELBW infants (<1000g birth weight) with primary severe prolongation of prothrombin time or development of severe prothrombin prolongation during sequential monitoring may have more frequent and more severe bleeding incidents (Intraventricular haemorrhage and pulmonary haemorrhage). The investigators aim to explore whether monitoring of PT can predict bleeding events in ELBW children.


Condition Intervention
Intraventricular Haemorrhage
Pulmonary Haemorrhage
Device: Coaguchek

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prediction of Major Bleeding in Extremely Low Birth Weight Infants (<1000g) by Sequential Coagulation Monitoring

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • major bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    pulmonary bleeding, intraventricular hemorrhage


Secondary Outcome Measures:
  • mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 126
Study Start Date: October 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Coaguchek
infants will receive sequential coagulation checks
Device: Coaguchek
The investigators plan to draw 10μL blood (i.e. approximately 1/5000 of the blood volume of an ELBW infant) within the scope of routine blood sampling. Thus, the number of blood samples will be variable. A cumulative sample volume for the whole study period will not exceed 300μL.

Detailed Description:

It was recently reported that "early", i.e. in the first 48h of life, coagulation screening may identify infants at risk of severe IVH. Unfortunately, in the past screening for coagulation abnormalities and correction of haemostatic defects by prothrombin complex concentrate, cryoprecipitate or platelet concentrates) and fresh frozen plasma (FFP) had limited effects in preterm infants. This could have been due to the short duration of action, incomplete restoration of coagulation or the water and osmotic load associated with FFP administration. However recently, using a coagulopathy screening strategy (one blood sample within the first 2h after birth) and substitution with FFP decreased the risk of developing IVH in infants born at 23 to 26 weeks of gestation. Recombinant Factor VII (rFVII) provides a new therapeutic option to overcome FFP associated side effects. Small trials, including infants with pulmonary hemorrhage, showed the safety and effectiveness of rFVII in VLBW infants; however no randomised controlled trials have been published so far. As outlined above, bleeding complications are still a major problem in extremely low birth weight (ELBW) infants and coagulation abnormalities are associated with bleeding. Up to now, only data about early and single screening exist and coagulation monitoring with multiple blood sampling was not applied.

In neonatal practice, coagulation abnormality in preterm babies is primarily investigated by measuring prothrombin time (PT). In fact, FVII activity, which is an important determinant of PT, is strongly associated with bleeding risk. Thus, a method to measure PT with small volume samples (10μL) provides the possibility for serial monitoring even in ELBW infants.

Substitution of FFP seemed beneficial in ELBW infants and first trials with rFVII revealed promising results in this patient population. Thus, coagulation monitoring might lead to early and adequate therapy and therefore to better outcome.

  Eligibility

Ages Eligible for Study:   up to 7 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preterm infants with a birth weight <1000g
  • signed informed consent

Exclusion Criteria:

  • Congenital heart disease
  • major congenital birth defects
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01976013

Contacts
Contact: Nadja Haiden, MD +431404003232 nadja.haiden@meduniwien.ac.at
Contact: Margarita Thanhaeuser, MD +431404003232 margarita.thanhaeuser@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Nadja Haiden, MD    +431404003232    nadja.haiden@meduniwien.ac.at   
Principal Investigator: Nadja Haiden, MD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Nadja Haiden, MD Medical University Vienna
  More Information

No publications provided

Responsible Party: Nadja Haiden,MD, Assoc.Prof.MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01976013     History of Changes
Other Study ID Numbers: MUV-Coagu
Study First Received: October 29, 2013
Last Updated: December 21, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
PT
INR
intraventricular haemorrhage
pulmonary haemorrhage
ELBW infants

Additional relevant MeSH terms:
Cerebral Hemorrhage
Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on March 25, 2015